Roche recalls cobas e 801 and cobas 8000 Modular Series analyzers due to potential plunger cracking causing impaired syringe function. Affected units have specific serial numbers.
The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.
Roche is recalling its cobas e 801 and cobas 8000 Modular Series analyzers because a tilted plunger could crack, leading to syringe function issues. This affects laboratory equipment used for medical testing.
The syringe plunger may be mounted at an angle, creating mechanical stress. If the plunger cracks, it can impair the syringe's function, potentially affecting medical test results.
Laboratories using the cobas e 801 or cobas 8000 Modular Series analyzers are affected. Lab technicians and medical staff who handle these devices are most at risk.
Check for serial numbers listed in the recall: 1744-03 through 17C6-02. The devices are part of Roche's cobas 8000 modular analyzer series for medical testing.
Verify if your device has a serial number from the list: 1744-03 through 17C6-02.
The syringe plunger may be mounted at an angle, creating mechanical stress that could cause it to crack, impairing syringe function.
Check if your device has a serial number from the list: 1744-03 through 17C6-02.
The recall does not require stopping use; affected units should be checked for serial numbers.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-2136-2018 — Roche Roche Hello, I own a Roche that is covered by recall Z-2136-2018 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
